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| A randomised controlled trial to investigate the clinical and cost effectiveness of adding an ablation device-based maze procedure as a routine adjunct to elective cardiac surgery for patients with pre-existing atrial fibrillation |
| Source of record | UK Trials |
| ISRCTN | ISRCTN82731440 |
| Date ISRCTN assigned | 04/04/2008 |
| Local reference number(s) | HTA 07/01/34 |
| Public title | A randomised controlled trial to investigate the clinical and cost effectiveness of adding an ablation device-based maze procedure as a routine adjunct to elective cardiac surgery for patients with pre-existing atrial fibrillation |
| Scientific title | |
| Acronym | The Amaze trial |
| Disease/condition/study domain | Patients with pre-existing atrial fibrillation (AF) requiring elective cardiac surgery |
| Study hypothesis | Treating a patient's atrial fibrillation (AF) by incorporating a modified maze procedure (using an AF ablation device) into their elective cardiac surgery will improve their quality of life as well as being cost effective from an NHS perspective. |
| Design/methodology | Multi-centre, prospective, randomised controlled trial. |
| Research ethics review | To be submitted as of 04/04/2008. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Age over 18, both men and women 2. Patients will have elective cardiac surgery planned (coronary surgery, valve surgery, combined coronary and valve surgery, any other cardiac surgery requiring cardiopulmonary bypass) 3. Patients will have a history of documented atrial fibrillation (chronic, persistent or paroxysmal) beginning more than 3 months before entry into the study 4. All patients will provide written informed consent to participation |
| Participants - exclusion criteria | 1. Patients with previous cardiac operations 2. Patients having emergency or salvage cardiac operations 3. Patients whose surgery will not involve cardiopulmonary bypass 4. Patients who are unlikely to be available for follow-up over a two-year period 5. Patients who are deemed not competent to provide consent |
| Patient information material | |
| Anticipated start date | 01/09/2008 |
| Anticipated end date | 01/03/2012 |
| Status of trial | Ongoing |
| Target number of participants | 400 |
| Interventions | Elective cardiac surgery with or without addition of ablation device-based maze procedure as adjunct. Contact details of Chief Investigator: Mr Sam Nashef Department of Surgery Papworth Hospital NHS Foundation Trust Papworth Everard Cambridge CB23 3RE United Kingdom |
| Primary outcome measure(s) | Patient benefit will be assessed by the following: 1. Rate of return to stable sinus rhythm (SR) at 12 months. Seven day electrocardiogram (ECG) monitors will be used to assess the predominant rhythm (SR or AF) and the AF load i.e. the percentage of time that the patient is in AF if their predominant rhythm is SR 2. Quality-adjusted survival over 2 years |
| Secondary outcome measure(s) | The following will be assessed at 6, 12 and 24 months and annually thereafter, except where indicated otherwise: 1. Cost-effectiveness for the NHS will be assessed by collecting resource use data and costs incurred by both groups and comparing their costs per quality-adjusted life year (QALY). Further longer term economic modelling will also be undertaken. 2. Other secondary objectives will be to determine whether the adjunct ablation device-based procedure: 2.1. Improves the rate of return to stable SR at 24 months after surgery 2.2. Improves atrial function (i.e. increases atrial transport ¿ assessed by echocardiography) 2.3. Decreases thromboembolic neurological complications (e.g. stroke) 2.4. Enables anticoagulant treatment to be withdrawn safely 2.5. Enables safe reduction or withdrawal of antiarrhythmic medication |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | Papworth Hospital NHS Foundation Trust (UK) |
| Sponsor details | c/o Dr Hester Goddard R&D Unit Cardiothoracic BioIncubator (CTBI) Building Papworth Hospital NHS Foundation Trust Papworth Everard Cambridge United Kingdom CB23 3RE |
| Sponsor telephone | +44 (0)1480 364181 |
| Sponsor fax | +44 (0)1480 364550 |
| Sponsor email | hester.goddard@papworth.nhs.uk |
| Sponsor website | http://www.papworthhospital.nhs.uk |
| Contact name | Dr Hester Goddard |
| Contact details | R&D Unit Cardiothoracic BioIncubator (CTBI) Building Papworth Hospital NHS Foundation Trust Papworth Everard Cambridge United Kingdom CB23 3RE |
| Contact telephone | +44 (0)1480 364181 |
| Contact fax | +44 (0)1480 364550 |
| Contact email | hester.goddard@papworth.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN82731440 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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